Diversatek Healthcare: Medical Device Recall in 2023 - (Recall #: Z-2521-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

ZVU Functional GI Software, REF: ZVU-3

Product Classification:

Class III

Date Initiated: July 25, 2023

Date Posted: September 13, 2023

Recall Number: Z-2521-2023

Event ID: 92854

Reason for Recall:

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

Status: Ongoing

Product Quantity: 20

Code Information:

UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023

Distribution Pattern:

worldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY, OR, FL, GA, NY, TX, CO, KS and the countries of Japan, Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated